Fludarabine

Generic Name: Fludarabine

Brand Names: Fludara

Drug Type: Small Molecule

Chemical Formula: C_₁₀H_₁₂FN_₅O_₄

CAS Number: 21679-14-1

Unique Ingredient Identifier: P2K93U8740

Background: Fludarabine is a chemotherapeutic agent used in the treatment of hematological malignancies. It is commonly marketed under the brand name Fludara.

Indication: For the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen

Associated Conditions: B-cell chronic lymphocytic leukemia/prolymphocytic leukemia/small lymphocytic lymphoma refractory, Refractory Non-Hodgkin's lymphoma

Associated Therapies: -

Clinical Trials

CD34+ Transplants for Leukemia and Lymphoma

Phase 2

Not yet recruiting

Conditions: Leukemia, Lymphocytic, Acute
Leukemia, Myeloid, Acute

Interventions: Radiation: Total Body Irradiation (TBI)
Drug: Busulfan
Drug: Thiotepa
Drug: Melphalan
Drug: Cyclophosphamide
Drug: Fludarabine

First Posted Date: 2022-10-04

Last Posted Date: 2024-11-25

Lead Sponsor: Guenther Koehne

Target Recruit Count: 100

Registration Number: NCT05565105

Locations: 🇺🇸
Baptist Health South Florida/Miami Cancer Institute, Miami, Florida, United States

Allogenic CD19-targeting CAR-γδT Cell Therapy in r/r NHL

Phase 1

Recruiting

Conditions: Non Hodgkin's Lymphoma

Interventions: Biological: Allogenic CD19-CAR-γδT cell
Drug: Fludarabine
Drug: Cyclophosphamide

First Posted Date: 2022-09-26

Last Posted Date: 2024-11-28

Lead Sponsor: Chinese PLA General Hospital

Target Recruit Count: 30

Registration Number: NCT05554939

Locations: 🇨🇳
School of phamaceutical, Tsinghua University, Beijing, Beijing, China
🇨🇳
Biotherapeutic Department, Chinese PLA General Hospital, Beijing, China

Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies

Phase 2

Active, not recruiting

Conditions: Relapsed/Refractory Hairy Cell Leukemia
Relapsed/Refractory Burkitt Lymphoma
Relapsed/Refractory Waldenstrom Macroglobulinemia
Relapsed/Refractory Richter Transformation

Interventions: Biological: Brexucabtagene Autoleucel
Drug: Cyclophosphamide
Drug: Fludarabine

First Posted Date: 2022-09-13

Last Posted Date: 2024-07-31

Lead Sponsor: Kite, A Gilead Company

Target Recruit Count: 19

Registration Number: NCT05537766

Locations: 🇺🇸
Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸
Georgetown University Medical Centre, Washington, District of Columbia, United States
🇮🇹
IRCCS Azienda Ospedaliero - Universitaria di Bologna, Bologna, Italy

and more 23 locations

Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics

Phase 1

Recruiting

Conditions: Myelodysplastic Syndrome (MDS)
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Acute Myeloid Leukaemia (AML)

Interventions: Drug: Treosulfan
Drug: Fludarabine

First Posted Date: 2022-09-09

Last Posted Date: 2024-02-21

Lead Sponsor: medac GmbH

Target Recruit Count: 36

Registration Number: NCT05534620

Locations: 🇺🇸
University of Illinois, Chicago, Illinois, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
The Ohio State University, Columbus, Ohio, United States

and more 1 locations

Exploratory Study of Novel MSLN CAR-T Cell Therapy in Patients With MSLN-positive Advanced Refractory Solid Tumors

Phase 1

Withdrawn

Conditions: Mesothelin-positive Advanced Refractory Solid Tumors

Interventions: Biological: Anti-mesothelin CAR-T cells
Drug: Fludarabine
Drug: Cyclophosphamide

First Posted Date: 2022-09-08

Last Posted Date: 2023-03-01

Lead Sponsor: Shanghai Pudong Hospital

Registration Number: NCT05531708

Locations: 🇨🇳
Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center, Shanghai, Shanghai, China

Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies

Phase 1

Recruiting

Conditions: Relapsed/Refractory Hematological Malignancies
Lymphoma
Myeloma
Leukemia

Interventions: Biological: Autologous CAR-T cells
Drug: Fludarabine
Drug: Cyclophosphamide

First Posted Date: 2022-09-06

Last Posted Date: 2022-09-06

Lead Sponsor: The Affiliated People's Hospital of Ningbo University

Target Recruit Count: 10

Registration Number: NCT05528887

Locations: 🇨🇳
The Affiliated People's Hospital of Ningbo University, Ningbo, Zhejiang, China

A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias

Phase 1

Withdrawn

Conditions: Acute Leukemias
Acute Leukemia of Ambiguous Lineage
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia

Interventions: Drug: JNJ-75276617
Drug: Fludarabine
Drug: Cytarabine
Drug: Intrathecal Chemotherapy
Drug: Dexamethasone
Drug: Vincristine
Drug: Pegaspargase

First Posted Date: 2022-08-30

Last Posted Date: 2024-08-22

Lead Sponsor: Janssen Research & Development, LLC

Registration Number: NCT05521087

Locations: 🇺🇸
Memorial Sloan Kettering, New York, New York, United States
🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

and more 8 locations

Novel CAR-T Cell Therapy in the Treatment of Hematopoietic and Lymphoid Malignancies

Phase 1

Withdrawn

Conditions: Multiple Myeloma (MM)
B-cell Acute Lymphoblastic Leukemia (B-ALL)
Acute Myeloid Leukemia (AML)
B-cell Non-Hodgkin's Lymphoma (B-NHL)
T-Cell Leukemia/Lymphoma, Adult

Interventions: Biological: Autologous CAR-T cells
Drug: Fludarabine
Drug: Cyclophosphamide

First Posted Date: 2022-08-24

Last Posted Date: 2023-03-01

Lead Sponsor: Shanghai Pudong Hospital

Registration Number: NCT05513612

Locations: 🇨🇳
Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center, Shanghai, Shanghai, China

Early Trial of Allogeneic Hematopoietic Stem Cell Transplantation for Patients Who Will Receive a Kidney Transplant From the Same Donor

Phase 1

Recruiting

Conditions: FSGS
SLE Nephritis
SIOD
Cystinosis
CKD Stage 4

Interventions: Drug: Cyclophosphamide 1200 mg/Kg
Drug: Cyclophosphamide 100 mg/Kg
Drug: Fludarabine
Radiation: Total Body Irradiation
Drug: ATG
Drug: Rituximab
Device: CliniMACS® TCR α/β Reagent Kit and CliniMACS® CD19 System
Drug: Melphalan
Procedure: Kidney Transplant

First Posted Date: 2022-08-19

Last Posted Date: 2023-07-17

Lead Sponsor: Alice Bertaina

Target Recruit Count: 12

Registration Number: NCT05508009

Locations: 🇺🇸
Lucile Packard Children's Hospital, Palo Alto, California, United States

A Pilot "Window-3" Study of Acalabrutinib Plus Rituximab Followed by Brexucabtagene Autoleucel Therapy in Patients With Previously Untreated High-risk Mantle Cell Lymphoma

Early Phase 1

Recruiting

Conditions: Lymphoma
Mantle Cell Lymphoma

Interventions: Drug: Acalabrutinib
Other: Brexucabtagene Autoleucel
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Fludarabine Phosphate

First Posted Date: 2022-08-10

Last Posted Date: 2024-10-24

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 20

Registration Number: NCT05495464

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Drug Development Updates

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